19. The Committee recalled that it had first considered this issue formally at its 19th Session. The Committee at its 20th Session (1995) had accepted the criteria-based approach in principle and agreed to draw up detailed working guidelines for its operation including the definitions and selection of the criteria to be used. The Committee at its last session had agreed that the paper should be revised by the Delegations of Canada, France and the United Kingdom and that trade dispute situations should also be addressed. The Committee agreed to discuss matters regarding trade dispute situations separately from the criteria approach at its present Session.
20. The Delegation of the United Kingdom presented the referenced paper[7] and explained that the objective of the criteria approach was to simplify the endorsement procedure for methods of analysis for chemical entities, and to provide for flexibility in selecting methods of analysis for such analytes. It was stated that the quality standard of analytical laboratories and the way in which they operate had dramatically changed due to quality assurance systems such as proficiency testing and accreditation. He stressed that the criteria approach was not intended to downgrade methods of analysis. Given the current confusion caused by the existence of multiple Type III methods, the Delegation urged the Committee to proceed with the criteria approach and proposed amendments to the relevant sections of the Codex Alimentarius Commission Procedural Manual in order for this Committee to implement the criteria approach.
21. The Committee confirmed its previous general acceptance of the criteria approach for methods of analysis for chemical entities. A majority of delegations wished to proceed with the approach. A number of delegations stated that only methods validated through inter-laboratory studies should be used and that analytical laboratories should be operating under quality assurance systems and/or good laboratory practices.
22. Many delegations expressed their preference of the criteria approach for flexibility it provided, in respect of the selection of methods or the availability of equipment. It was also stated that in order to achieve better results of analyses, it was desirable to be allowed to use those methods in which analysts were experienced. The Delegation of Ireland presented their experience in using both official methods and the criteria approach. It was stated that, if backed up by an appropriate quality assurance system, the criteria approach was found suitable to be used also in court. The Delegation stated that in the future more labs would seem to use the criteria approach.
23. Some delegations proposed that the Codex method Types II and III should be combined to provide for more flexibility. However, several other delegations were in favour of retaining the Type II classification stating the usefulness of these reference methods in relation to trade disputes or for use in the validation of alternative (automated) methods or calibration of new methods. The Committee for the time being did not wish to change the method classification.
24. Concerns were expressed on the number and selection of criteria to be used in this approach. The Committee recalled that it had already agreed that this Committee would convert methods proposed by the commodity committee into criteria. Some delegations and observers questioned the need for nine criteria which could lead to a possibility to exclude appropriate methods from selection for Codex purposes due to trivial criteria (see para. 66) or could necessitate redesigning of collaborative studies. Some delegations proposed to change the terms for certain criteria and to identify some of them as optional.
25. The Committee noted that some organizations of the Inter-Agency Meeting has included performance characteristics in the methods or appendices thereof, while some others had not done so. If required by this Committee, other organizations would place the information in the methods themselves. (see para. 65)
26. The Committee decided to proceed with the implementation of the criteria approach including amendments of the relevant sections of the Codex Alimentarius Commission Procedural Manual. (see below)
Guidelines on the Application of the Criteria Approach by the Codex Committee on Methods of Analysis and Sampling
27. In accordance with the decision above, the Committee decided to prepare working guidelines for this Committee for implementation of the criteria approach. The Committee requested the United Kingdom, together with Canada, Australia, Finland, France, Germany, Netherlands, Norway, United States and the Codex Secretariat, to prepare a draft of the guidelines for consideration at its next Session. In drafting the document the content of the Recommendations for a Checklist of Information Required to Evaluate Methods of Analysis and Sampling for Endorsement[8] should be taken into consideration. If the paper was to contain examples, they should be drafted in such a way that they would provide practical instructions on the implementation of the criteria approach.
Amendments of the Relevant Sections of the Codex Alimentarius Commission Procedural Manual
28. The Committee agreed to seek approval of the Commission to initiate work on the amendments of the sections of the Codex Alimentarius Commission Procedural Manual, “Principles for the Establishment of Codex Methods of Analysis” and “Relations between Commodity Committees and General Committees – Methods of Analysis and Sampling”. It also agreed to request comments from Member countries on the text as contained in page 7 of CX/MAS 98/5 at Step 3. However, as the Delegation of the United States strongly opposed to include “Type II” method in the criteria approach, the Committee decided to place the term “II and” in square brackets for future consideration. The text as amended is attached to this Report as Appendix II.
Dispute Situations
29. The Delegation of France presented Annex IV of the referenced paper and recalled that at the last Session the Delegations of the United States and France had expressed concerns that how to deal with trade dispute situations had not been fully addressed in CX/MAS 97/3. The Delegation explained that the annex included all possible trade dispute situations envisaged. The settlement procedure started with the comparison of the results of the export laboratory and import laboratory. If no agreement was reached in this phase, the two laboratories should first agree to the method to be used for a new analysis. If no agreement was yet obtained after the second analysis, they should take new samples according to the procedure specified in the annex. Further settlement would involve an arbitrating laboratory. The Delegation also mentioned other conditions such as quality assurance of the laboratory and archives of samples.
30. Many delegations highly appreciated the annex for its illustration of all possible scenarios. However, the Delegation of the United States stated that within its governmental system, it would not be possible to delegate authority to third parties.
31. Recognizing that the Codex Committee on Food Import and Export Inspection and Certification System is the Committee which deals with horizontal issues relating to food import and export, the Committee agreed to refer Annex IV of CX/MAS 98/5 to that Committee.
